Glenmark to Commence New Phase 3 Clinical Trial on Combination of Two Anti-viral Drugs Favipiravir and Umifenovir in Hospitalized Patients of Moderate COVID-19 in India

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• USA - English

- Glenmark received approval from Indian regulator to initiate study

- Early treatment with combination therapy will be evaluated for safety and efficacy as it is emerging as an effective approach in shortening duration of virus shedding, decreasing cytokine response, and facilitating early discharge of patients¹

- Glenmark also continues its Phase 3 clinical trials on antiviral Favipiravir monotherapy for COVID-19 patients in India

MUMBAI, India  and MAHWAH, New Jersey, May 26, 2020 /PRNewswire/ --  Glenmark Pharmaceuticals, a global pharmaceutical company, announced a new randomized, open-label study to test the combined efficacy of two antiviral drugs Favipiravir and Umifenovir as a potential COVID-19 treatment strategy.

Favipiravir is an oral antiviral drug approved in Japan since 2014. It has a unique mechanism of action by which it inhibits viral replication: Umifenovir is another oral antiviral drug licensed for treatment and prophylaxis of influenza A and B infections in Russia and China. Umifenovir impedes the viral attachment to cells and acts as a viral entry inhibitor. Additionally it exhibits modulatory effects on the immune system and induces interferon-production. Hence combined use of Favipiravir and Umifenovir acting on different mechanisms offers a comprehensive antiviral cover on pre-entry and post-entry life-cycle of the SARS-CoV-2 virus. Both antivirals inhibited virus infection in vitro and have shown efficacy in COVID-19 clinical trials. The current Glenmark study will examine whether early administration of this combination, both acting by different mechanisms, enhances antiviral efficacy on COVID-19 patients.

The new combination clinical trial will be called FAITH – (FA vipiravir plus Um I fenovir (efficacy & safety) T rial in Indian H ospital setting). 158 hospitalized patients of moderate COVID-19 infection will be enrolled in the combination study and randomized in two groups: one group receiving Favipiravir and Umifenovir (with standard supportive care); and one group receiving Favipiravir along with standard supportive care. Patients in the arm receiving the drug will receive Faviprivir 1800mg bid and Umifenovir 800 mg bid on Day 1. Thereafter patients would receive Faviprivir 800mg bid and Unifenovir 800mg bid for the remaining course of the treatment. Duration of treatment will be 14 days and patients will be discharged after clinical cure and two consecutive negative tests for COVID-19 based on RT-PCR.

Simultaneously Glenmark is conducting phase 3 clinical trials of Favipiravir as a COVID-19 monotherapy option with 150 patients, enrolled from 9 leading government and private hospitals across India.

About Glenmark Pharmaceuticals Ltd.

Glenmark Pharmaceuticals Ltd. (GPL) is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries. Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology. It is ranked among the top 80 Pharma & Biotech companies of the world in terms of revenue (SCRIP 100 Rankings published in the year 2019). For more information, visit www.glenmarkpharma.com

SOURCE Glenmark Pharmaceuticals Ltd.